The controlled agglomeration method is disclosed in International Patent Application No. PCT/DK02/00472 assigned to the present Applicant. The method enables preparation of pharmaceutical compositions for oral use that release the active substance from the composition in a suitable manner to enable an absorption of the active substance into the circulatory system.
A controlled agglomeration process may for example be carried out in a high or low shear mixer or in a fluid bed. According to the method, a carrier or a carrier composition is sprayed on a second composition, which is loaded into the mixer or the fluid bed. Typically, the carrier or the carrier composition is heated to a temperature above the melting point of the carrier and/or the carrier composition while the second composition is not subjected to any heating and thus, stays at ambient temperature. The difference in temperature between the carrier and the second composition makes the carrier solidify rapidly which in turn leads to a controlled growth of the particle size. Thus, the inventors have found that by employing such conditions it is possible to control the agglomeration process so that the growth in particle size is controlled.
Throughout the present description, the term “carrier” is used as an abbreviation of the term “carrier composition”. A carrier composition comprises one or more carriers, optionally together with one or more other ingredients. Thus, the carrier composition may comprise a mixture of hydrophilic and/or hydrophobic carriers and/or surfactants. The carrier composition may also comprise one or more therapeutically and/or prophylactically active substances and/or one or more pharmaceutically acceptable excipients.